Ixabepilone in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer That Has Not Responded to Previous Chemotherapy

National Cancer Institute (NCI)

Status and phase

Completed

Phase 2

Conditions

Primary Peritoneal Cavity Cancer

Recurrent Ovarian Epithelial Cancer

Treatments

Drug: ixabepilone

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT00025155

CDR0000068927

GOG-0126M (Other Identifier)

U10CA027469 (U.S. NIH Grant/Contract)

NCI-2012-02413 (Registry Identifier)

Details and patient eligibility

About

Phase II trial to study the effectiveness of ixabepilone in treating patients who have recurrent or persistent ovarian epithelial or primary peritoneal cancer that has not responded to previous chemotherapy. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die.

Full description

PRIMARY OBJECTIVES:

I. Determine the antitumor activity of ixabepilone in patients with recurrent or persistent platinum and paclitaxel-refractory ovarian epithelial or primary peritoneal cancer.

II. Determine the nature and degree of toxicity of this drug in these patients.

OUTLINE:

Patients receive ixabepilone IV over 1 hour. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Enrollment

51 patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Histologically confirmed ovarian epithelial cancer or primary peritoneal cancer
- Recurrent or persistent disease
- Platinum AND taxane-resistant or refractory disease
  - Progressed during therapy
  - Refractory disease within 6 months of therapy
Measurable disease
- At least 20 mm by conventional techniques
- At least 10 mm by spiral CT scan
- Tumor lesions located within a previously irradiated field are not considered measurable disease unless there is documented tumor progression in these lesions or biopsy confirmation ≥ 90 days following completion of radiotherapy
Ineligible for higher priority GOG (Gynecologic Oncology Group) protocol
No active brain metastases
Performance status - GOG 0-2
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Bilirubin ≤ 1.5 times upper limit of normal (ULN)
SGOT (serum glutamate oxaloacetate transaminase) ≤ 2.5 times ULN
Alkaline phosphatase ≤ 2.5 times ULN
Creatinine ≤ 1.5 times ULN
No sensory or motor neuropathy > grade 1
No dementia or altered mental status
No other serious uncontrolled medical disorder
No active infection requiring antibiotics
No prior hypersensitivity reaction to paclitaxel or other therapy containing Cremophor EL
No other malignancy within the past 5 years except nonmelanoma skin cancer
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
At least 3 weeks since prior biologic therapy
At least 3 weeks since prior immunotherapy
Must have received:
- 1 prior combination taxane-based and platinum-based chemotherapy regimen
- 1 prior platinum-based chemotherapy regimen AND 1 prior taxane-based chemotherapy regimen
Initial treatment may include high-dose therapy, consolidation, or extended therapy
At least 3 weeks since prior chemotherapy and recovered
No prior ixabepilone
No other prior cytotoxic chemotherapy for recurrent or persistent disease, including treatment with initial regimen
At least 1 week since prior hormonal anticancer therapy
Concurrent hormone replacement therapy allowed
At least 3 weeks since prior radiotherapy and recovered
No prior radiotherapy to site(s) of measurable disease
No radiotherapy to > 25% of marrow-containing areas
Recovered from recent surgery
At least 3 weeks since other anticancer therapy
No prior anticancer therapy that precludes study participation
No concurrent food supplements (e.g., St. John's wort)
No concurrent amifostine or other protective agents